Biological Material Transfer Agreement
Samples and Data for Research: Template for Access Policy Development from the National Cancer Research Institute http://www.oncoreuk.org/pages/researchers_data.html
Uniform Biological Material Transfer Agreement Federal Register http://www.nhlbi.nih.gov/resources/tt/docs/ubmta.pdf
Code of Federal Regulations
Government Printing Office Access http://www.gpoaccess.gov/cfr/index.html
Conflict of Interest
Conflict of Interest, NIH Office of Extramural Research http://grants.nih.gov/grants/policy/coi/
Conflict of Interest Information and Resources, NIH< http://www.nih.gov/about/ethics_COI.htm
Electronic Records and Electronic Signatures
Electronic Records; Electronic Signatures
Office of Regulatory Affairs, U.S. Food and Drug Administration
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1
Health Information Portability and Accountability Act of 1996
Health Information Portability and Accountability Act of 1996
HIPAA Security Rule
Centers for Medicare and Medicaid Services
Department of Health and Human Services
http://www.cms.gov/HIPAAGenInfo/
Medical Privacy–National Standards to Protect the Privacy of Personal Health Information
Office for Civil Rights–HIPAA
Office for Civil Rights
Department of Health and Human Services
http://www.hhs.gov/ocr/hipaa/
Human Subjects Regulations
Application for and exemption from IRB approval
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/hsdc95-02.html
Frequently asked questions
Office for Human Research Protections
Department of Health and Human Services
http://answers.hhs.gov/ohrp/
Genetic Information Nondiscrimination Act of 2008
http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.00493:
Genetic Nondiscrimination Fact Sheet
http://www.genome.gov/10002328
Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards
http://www.hhs.gov/ohrp/policy/gina.pdf
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Food and Drug Administration http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm078384.htm
Guidance on Research Involving Coded Private Information or Biological Specimens
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/cdebiol.html
Human Subjects Policy Guidance
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/index.html#human
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/
Informed Consent Policy Guidance
Issues to Consider in the Research Use of Stored Data or Tissues
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/reposit.html
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/index.html#informed
Policies for responding to requests for discontinuation of participation in research
Office for Human Research Protections
Department of Health and Human Services
http://www.hhs.gov/ohrp/policy/subjectwithdrawal.pdf
http://www.hhs.gov/ohrp/documents/200811guidance.html
http://edocket.access.gpo.gov/2008/pdf/E8-28387.pdf
Informatics Interoperability
caGrid
http://cagrid.org/display/cagridhome/Home
Cancer Data Standards Repository
https://cabig.nci.nih.gov/concepts/caDSR/
Specimen Resource Locator
http://biospecimens.cancer.gov/locator
Informatics System Development
Capability Maturity Model Integration
Carnegie Mellon® Software Engineering Institute
http://www.sei.cmu.edu/cmmi/
Informatics System Security
Risk Management Guide for Information Technology Systems
National Institute of Standards and Technology
http://csrc.nist.gov/publications/nistpubs/800-30/sp800-30.pdf
Laboratory Practices
Clinical Laboratory Improvement Amendment
http://wwwn.cdc.gov/clia/regs/toc.aspx
Good Laboratory Practices http://www.oecd.org/document/63/0,2340,en_2649_34381_2346175_1_1_1_1,00.html
International Organization for Standardization (ISO9000)
http://www.iso.org/iso/home.htm
ISBER
http://www.isber.org
U.S. Food and Drug Administration (FDA) Quality System Regulation, 21 CFR 820
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
National Cancer Institute
Biospecimen Research Network
http://biospecimens.cancer.gov/researchnetwork/
cancer Biomedical Informatics Grid®
https://cabig.nci.nih.gov/
cancer Biomedical Informatics Grid® Enterprise Support Network
http://cabig.nci.nih.gov/esn/
Data Sharing and Intellectual Capital Workspace
http://cabig-ut.nci.nih.gov/working_groups/DSIC_SLWG
National Biospecimen Network Blueprint
http://biospecimens.cancer.gov/archive/resources/reports/nbn.asp
NCI Best Practices Frequently Asked Questions
http://biospecimens.cancer.gov/practices/faq.asp
Office of Biorepositories and Biospecimen Research
http://biospecimens.cancer.gov/
Symposium-Workshop on Custodianship and Ownership Issues in Biospecimen Research
http://biospecimens.cancer.gov/archive/resources/workshop/cow.asp
National Institutes of Health Policies and Guidelines
Certificates of Confidentiality Kiosk
Office of Extramural Research
National Institutes of Health
http://grants2.nih.gov/grants/policy/coc/index.htm
Conflict of Interest
Office of Extramural Research
National Institutes of Health
http://grants.nih.gov/grants/policy/coi/
Guidelines for Research Involving Recombinant DNA Molecules
Office of Biotechnology Activities
National Institutes of Health
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html
NIH Data Sharing Policy
Office of Extramural Research
National Institutes of Health
http://grants.nih.gov/grants/policy/data_sharing/
NIH Research Tools Policy
Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts
Office of Technology Transfer
National Institutes of Health
http://ott.od.nih.gov/policy/research_tool.html
Other Biospecimen Resource References
Case Studies of Existing Human Tissue Repositories—“Best Practices” for a Biospecimen Resource for the Genomic and Proteomic Era
http://biospecimens.cancer.gov/archive/resources/reports/csehtr.asp
http://www.rand.org/pubs/monographs/MG120/index.html
Handbook of Human Tissue Sources—A National Resource of Human Tissue Samples
http://www.rand.org/pubs/monograph_reports/MR954/
Standardized Systems for Clinical and Pathology Data
American Joint Committee on Cancer TNM Staging
http://www.cancerstaging.org/mission/whatis.html
Cancer Care Ontario Program in Evidence-Based Care
http://www.cancercare.on.ca/cms/One.aspx?portalId=1377&pageId=10151
College of American Pathologists Cancer Protocols and Checklists
http://tinyurl.com/CAPProtocols
International Classification of Diseases
http://www.who.int/classifications/icd/en/
International Classification of Diseases for Oncology
http://www.who.int/classifications/icd/adaptations/oncology/en/index.html
National Comprehensive Cancer Network Guidelines and Clinical Resources
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp
North American Association of Central Cancer Registries Data Standards and Data Dictionary
http://www.naaccr.org/StandardsandRegistryOperations/VolumeII.aspx
Systematized Nomenclature of Medicine—Clinical Terms® (SNOMED CT)
http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html
